System and method for tracking medical imaging quality

ABSTRACT

The mammography management system can provide for quality control of devices associated with the system. A method is provided for monitoring the quality standards of a mammography facility. The method can comprise generating a report that analyzes information collected in preselected data fields on the performance of a resource after automatically executing a quality control test plan configured for the resource at a preselected time. The quality control test plan is configured based on resource type. 
     A method can provide for monitoring the quality of exams performed on a plurality of patients. The method comprises generating a report automatically analyzing and organizing information collected on the accuracy of exams preformed on the plurality of the patients into statistics. These statistics can compare the information based on a radiologist or a facility with other radiologists other facilities or overall statistics for a plurality of radiologists or a plurality of facilities.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application No.60/742,668, filed Dec. 6, 2005, and U.S. Provisional Application No.60/613,054, filed Jan. 19, 2005, and the contents of which areincorporated herein in their entirety.

BACKGROUND OF THE INVENTION

Current breast imaging technology presents a variety of challenges forthose involved with the practice of mammography. Among those challengesare low reimbursement rates, diminishing availability of fellowshiptrained radiologists, decreasing numbers of mammography facilities,integration complexity, high cost of human resources and errors, andMQSA compliance. Additionally, despite the growth in full-field digitalmammography, the introduction of digital imaging has provided a varietyof opportunities to breast imaging technology that have not been fullyrealized.

BRIEF SUMMARY OF THE INVENTION

In accordance with one embodiment of the present invention, a method ina computer system is provided for managing mammography examinationinformation. The method includes receiving electronically personalinformation of a patient, such as name, demographic information, andinsurance information. Next, digital mammography images of the patientare produced by a modality for a screening examination and/or diagnosticexamination, and mammography procedure results data is generated thatreflect the results of a procedure examination, such as a biopsy. Then,the personal information, digital images, and procedure data of the userare stored in a database and are logically linked to each other.

When a system user, such as a radiologist, is prepared to interpretexamination results, the digital images and procedure data of the userare electronically displayed to the user responsive to a user request.At least a first portion of the digital images is electronicallyretrieved from the database, and at least a second portion of thedigital images is retrieved from a Picture Archive and CommunicationsSystem (PACS). Data from the user representing a medical interpretationof said digital images and procedure data are received, and a medicalreport based on the medical interpretation is automatically generatedresponsive to receipt of the interpretation.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a diagram of an exemplary user interface for an image viewingsoftware screen in accordance with one specific implementation.

FIG. 2 is a block diagram of an exemplary computer system that can beused to implement various described embodiments.

FIG. 3 is a block diagram of another exemplary computer system that canbe used to implement various described embodiments.

FIG. 4 is a block diagram of yet another exemplary computer system thatcan be used to implement various described embodiments.

FIG. 5 is a diagram of an exemplary user interface for a user accountscreen in accordance with one specific implementation.

FIG. 6 is a diagram of an exemplary user interface for a facilityschedule configuration screen in accordance with one specificimplementation.

FIG. 7 is a diagram of an exemplary user interface for a schedule dayview screen in accordance with one specific implementation.

FIG. 8 is a diagram of an exemplary user interface for a createappointment dialog screen in accordance with one specificimplementation.

FIG. 9 is a diagram of an exemplary user interface for a viewappointment dialog screen in accordance with one specificimplementation.

FIG. 10 is a flow diagram that describes steps in a appointment workflowmethod in accordance with one described embodiment.

FIG. 11 is a flow diagram that describes steps in a method forperforming screening, diagnostic, and procedure examinations inaccordance with one described embodiment.

FIG. 12 is a flow diagram that describes steps in a method for creatingan exam record in accordance with one described embodiment.

FIG. 13 is a diagram of an exemplary user interface for a create examscreen in accordance with one specific implementation.

FIG. 14 is a diagram of an exemplary user interface for a start examscreen in accordance with one specific implementation.

FIG. 15 is a diagram of an exemplary user interface for a symptomrecordation screen in accordance with one specific implementation.

FIG. 16 is a diagram of an exemplary user interface for a search examscreen in accordance with one specific implementation.

FIG. 17 is a diagram of an exemplary user interface for a search examscreen in accordance with one specific implementation.

FIG. 18 is a diagram of an exemplary user interface for an exam worklistscreen in accordance with one specific implementation.

FIG. 19 is a diagram of an exemplary user interface for a facilitydashboard screen in accordance with one specific implementation.

FIG. 20 is a diagram of an exemplary user interface for a study worklistscreen in accordance with one specific implementation.

FIG. 21 is a diagram of an exemplary user interface for a compare/repeatexam list screen in accordance with one specific implementation.

FIG. 22 is a diagram of an exemplary user interface for a draft examlist screen in accordance with one specific implementation.

FIG. 23 is a diagram of an exemplary user interface for a callback examlist screen in accordance with one specific implementation.

FIG. 24 is a flow diagram that describes steps in a method for ascreening exam workflow in accordance with one described embodiment.

FIG. 25 is a diagram of an exemplary user interface for an exam resultsscreen in accordance with one specific implementation.

FIG. 26 is a diagram of an exemplary user interface for an add lesionscreen in accordance with one specific implementation.

FIG. 27 is a diagram of an exemplary patient letter screen in accordancewith one specific implementation.

FIG. 28 is a diagram of an exemplary exam report screen in accordancewith one specific implementation.

FIG. 29 is a diagram of an exemplary user interface for a view examscreen in accordance with one specific implementation.

FIG. 30 is a flow diagram that describes steps in a method for adiagnostic exam workflow in accordance with one described embodiment.

FIG. 31 is a diagram of an exemplary user interface for a diagnosticexam results screen in accordance with one specific implementation.

FIG. 32 is a diagram of an exemplary user interface for a patientsymptom diagram screen in accordance with one specific implementation.

FIG. 33 is a diagram of an exemplary user interface for a viewdiagnostic exam screen in accordance with one specific implementation.

FIG. 34 is a flow diagram that describes steps in a method for aprocedural exam workflow in accordance with one described embodiment.

FIG. 35 is a diagram of an exemplary user interface for a procedure examresults screen in accordance with one specific implementation.

FIG. 36 is a diagram of an exemplary user interface for a view procedureexam screen in accordance with one specific implementation.

FIG. 37 is a flow diagram that describes steps in a method of dataexchange in accordance with one described embodiment.

FIG. 38 is a diagram of an exemplary user interface for a MQSA auditscreen in accordance with one specific implementation.

FIG. 39 is a diagram of an exemplary user interface for a QC test plansetup screen in accordance with one specific implementation.

FIG. 40 is a QC Worksheet Screen.

FIG. 41 is a QC Dashboard Screen.

DETAILED DESCRIPTION OF THE INVENTION

System and Method Overview

The mammography management system and method of the present invention isa network-based solution that facilitates secure and efficientelectronic data movement. Because the system platform may be implementedin a web-based environment, it promotes access flexibility, whereinusers such as radiologists may connect and access the system resourcesfrom any connected location. The system provides various functionalitiesdescribed herein relating to mammography exams and informationmanagement and supports full-field digital mammography (FFDM).

The mammography management system and method of the present invention isreadily integrated with Picture Archive and Communications Systems(PACS), Hospital Information Systems (HIS), and Radiology InformationSystems (RIS), allowing for existing systems to continue to functionwith the additional benefits of the mammography management system of thepresent invention. HIS and RIS contain patient and examinationinformation, which are described in more detail below. When resourceswithin the mammography management system and PACS are connected to aHIS/RIS, the mammography workflow is made more efficient byelectronically transferring patient and examination data and informationto the appropriate workstation/user in the system of the presentinvention.

PACS is an image management and communication system that stores anddistributes digital images and is in communication with the mammographymanagement system. By integrating with PACS, the mammography managementsystem receives electronic image studies from PACS, which in turntriggers the advancement of the exam workflow. Images are generallymaintained and transferred using the Digital Imaging and Communicationsin Medicine (DICOM) standard, where DICOM is a protocol based standardthat facilitates the transfer of digital images and associatedinformation between devices.

As described in more detail below, the mammography management system ofthe present invention electronically associates studies received fromthe modality with the study request record, the exam, and the patientstored in the system. An integrated PACS system allows for digital imagecapture and storage, which are then automatically associated withpatient exams, or allows for scanning of analog images for comparisonwith more recent digital images. By electronically associating imagesand other information received by the mammography management system fromPACS or other systems, image retrieval, reporting, and otherfunctionality are enhanced and made more efficient.

The mammography management system is also integrated with image viewingsoftware appropriate for viewing mammography studies. A screenshot of anappropriate viewing application is shown in FIG. 1. The software isenhanced to allow for expedient transfer of medical images over thenetworked connections and resources. This integration also allows for asystem user, typically a radiologist, to instantaneously retrieve andview studies, and to automatically load related studies into the viewingsoftware onto suitable viewing station hardware that is appropriatelyconfigured. As described in more detail below, image viewing isintegrated with the exam workflow such that when a radiologist viewsexam data, the images are automatically displayed to him or her.

The mammography management system further includes electronic interfacesto various modalities, such as FFDM, sonography, bone density, soft copyworkstations (radiologist image viewer), and MRI modalities. Asdescribed in more detail below, the present invention includes a varietyof worklists that define and prioritize workflows for various activitiesor actions that will be performed. Where appropriate, the systemprovides for electronic interfaces with the modalities that allow formodality worklist download, thereby streamlining operations involvingthe various modalities.

As described in more detail herein, the system of the present inventionmay also include integration with various other components, includingintegrated digital signature capture for patients and physicians,integrated voice dictation for physicians, automatic PDF file generationof reports and letters, integrated fax solution for physician reports,and integrated MQSA reporting system. The reports and images are madeavailable to referring physicians via an integrated web portal.Additionally, quality assurance and quality control functionality forFFDM, sonography, and breast MRI modalities allows users to maintainpatient images, patient data, and modality data in a single system. Thesystem also incorporates MQSA and BI-RADS standards, thereby promotingportability and minimizing training time for new users.

System Architecture and User Portals

FIG. 2 shows a logical representation of the architecture of themammography management system of the present invention in one possibleconfiguration for a hospital implementation. Because the representationis logical rather than physical, those skilled in the art willappreciate that the physical implementation of the mammographymanagement may take the form of a variety of different embodiments,including one or more servers associated with one or more databases andother physical components for performing data management, userinterfaces generation, information storage, or performing otheroperations as described herein. In the configuration shown in FIG. 2,the mammography management system server 100 is integrated with existingHIS 110, PACS 120, and RIS 130 components. The server 100 may bephysically located at the hospital facility, remotely located as part ofa larger campus, or hosted by a third party. When the server 100 is notlocal to the hospital or other medical facility, the server and othercomponents of the mammography management system may communicate througha variety of suitable means, such as the Internet, frame relay, point topoint networking, or other appropriate architectures. The specificconfiguration of any installation of the mammography management systemmay vary while still remaining within the scope of the presentinvention.

FIG. 3 shows a logical representation of the mammography managementsystem in one possible configuration for a free-standing facilityimplementation. In the configuration shown in FIG. 3, the mammographymanagement system server 100 is integrated with an existing PACScomponent 120. In this embodiment, a user may view DICOM images at softcopy workstation (SCW) 140, provided from server 100 or modality 150.Generally, all code, operating systems, databases, and web serversreside on hard drives local to the server 100.

FIG. 4 shows a logical representation of the architecture of themammography management system in one possible configuration for asatellite mammography screening service implementation. Thisconfiguration includes optional on-site and/or off-site storageservices, storage area network (SAN) 160, which stores all relevantpatient information, such as images, patient data, and exam data. Thisconfiguration allows a satellite mammography screening facility andservice to benefit from the desired functionalities of a third partyprovider of the mammography management system.

Users of the system may include a variety of individuals such asradiologists, technologists, administrators, referring physicians,clerical and other facility employees, and, in some instances, patients(e.g., to sign or view disclosure information). As illustrated above,various system architectures are envisioned within the scope of thepresent invention, and the various system users may access the systemfrom a variety of resources and locations. For example, a technologistmay interact with the system via system interfaces provided at anynumber of tech stations located within a facility, whereas a radiologistmay interact with the system via system interfaces provided at either asoft copy workstation at a facility or at an Internet-connected computerat the radiologist's home. The architecture flexibility allows foraccommodating any desirable configuration of such portals or accesspoints to the mammography management system.

Users of the mammography management system connect to the system byfirst logging in to a system portal or access point prior to using anyof the management system functionality. The login requiresauthentication of the user and provisioning of user privileges based onhis or her assigned role. In order to access the portal the user mustprovide his or her username, password, and an optional crypto key.Successful login will establish a trusted session with the systemportal.

Access and login may be performed through a user interface via a webbrowser. When the username, password and crypto key number areauthenticated by the mammography management system server 100, theappropriate screen is displayed based on the user's predefined role.Predefined roles and corresponding screens may include the following:administrator/patient search screen; radiologist/pending exam screen;lead interpreting physician/exam search screen; systemadministrator/user search screen; and referring physician/exam searchscreen. For example, when an authorized radiologist logins, a “pendingexam” screen will be displayed.

With reference to FIG. 5, a user account screen 500 allows a user tomanage various information including office phone, home phone, cellphone, fax, email address, and password. Additional display ofsignature, screening schedule, facilities and linked physician recordare dependent on the account options for the user's roles. For example,for users identified as radiologists, a selection is made available fortoggling a “Available for Reading” setting 510, which indicates whetherthe radiologist is available to review studies.

System Exam Scheduling Functionality

The mammography management system appointment scheduling componentprovides a facility with appointment scheduling functionality. Thesystem provides each facility with a separate schedule of appointmentsacross the facility's defined resources. A resource is a generic termfor an entity that may be scheduled, such as staff, rooms, andequipment.

The scheduling functionality provides interfaces for a user to schedulepatient appointments to a specific resource/time intersection. Anappointment represents the time and resource at which a study will occurfor a patient. The scheduling component of the mammography managementsystem also maintains a schedule for each facility and allows a user tolimit the user or availability of resources to certain types of studies.The functionality further provides user interfaces that display lists offirst available appointments and that allow a user to select existingpatients stored in the mammography management system or create newpatients when an appointment is scheduled. The scheduling functionalityintegrates appointments with the exam/study creation processes describedbelow to exchange data and automatically populate fields containingpreviously acquired data.

The mammography management system appointment scheduling user interfaceprovides for various views/screens relating to scheduling to accomplishthe forgoing functionality. The Schedule Configuration screens allow thesystem user to configure hours of operation 610, time segmentation 620,and scheduled resources 630. An example of a Facility ScheduleConfiguration screen 600 is seen in FIG. 6. These configurations areperformed at the facility level. The Schedule View screens display to auser the appointment schedule for a specific facility through differentviews based on time span (e.g., daily, weekly, bi-weekly). An example ofa Schedule Day View screen 700 is seen in FIG. 7. The schedule viewscreens may also be used to locate and schedule new appointments. TheAppointment screens display an interface for creating, modifying,viewing and searching for patient appointments. An example of anincomplete Create Appointment Dialog screen 800 is seen in FIG. 8, andan example of a View Appointment Dialog screen 900 is seen in FIG. 9.The Appointment screens allow a user to link an appointment to anexisting patient record stored in the mammography management system.

With reference to FIG. 10, the Appointment Workflow 1000 in accordancewith one embodiment of the present invention is shown, illustrating theappointment statuses throughout the workflow. Typically, a patient callsa facility's appointment desk, and a “scheduler” or other system useranswers the phone, determines basic information about the appointment(e.g., type of study, which breast) and uses the Schedule View screensto locate an appropriate time slot. The scheduler then locates theexisting patient in the mammography management system, creates a newpatient, or takes basic information, enters the referring physician,saves the appointment using the Appointment Screens. At this point, theappointment is given a status in the mammography management system ofScheduled 1010. If the patient information was not previously stored orlocated in the mammography management system, the scheduler oradministrator user adds the new patient to the system by navigating tothe patient area and clicking on the “add” link in the patient searchscreen.

Optionally, a facility employee can call the patient to confirm theappointment prior to the actual appointment date/time. At this point,the appointment is given a status in the mammography management systemof Confirmed 1020. Prior to the appointment the patient may also calland cancel the appointment. The scheduler or other user of the systementers the cancellation into the mammography management system, and theappointment is given a status in the system of Cancelled 1030.

If the patient keeps the appointment, the patient typically arrives atthe facility and checks in with a front desk employee who enters thearrival into the mammography management system. At this point theappointment is given a status in the system of Arrived 1040, and arelated exam is created in the mammography management system asdescribed in more detail below. The mammography management system usermay also update the patient record with additional demographic orinsurance information. If the patient does not show up at the scheduledtime, the system user may mark the appointment as a “No Show” with alike status 1050.

When the appointment is in Arrived status, the mammography managementsystem employ the patient and appointment information to pre-create anexam 1060, as described in more detail below. A Create Exam screen isdisplayed to the user for verification and/or modification of the datafields. During this process an association between the Exam and theAppointment is created in the mammography management system database.

When the exam related to the appointment is started 1065 by atechnologist and is so indicated in the system, the appointment isautomatically given a status in the system of In Progress 1070. When thestudy related to the appointment is completed 1080 by the Technologistand is so indicated in the system, the appointment is automaticallygiven a status of Completed 1090.

System Exam Functionality

The mammography management system provides support and managementfunctionality for mammography screening exams, diagnostic exams, andprocedure exams. FIG. 11 depicts a procedural flow chart 1100 ofscreening, diagnostic and procedure exams and ACR results in an overallflow through one embodiment of the mammography management system. First,a screening exam 1110 may be scheduled and managed in the mammographymanagement system. When the screening exam uncovers an abnormality(e.g., ACR 0), the exam is recorded as a callback result. The patient isthen scheduled to obtain a diagnostic exam 1120. The diagnostic exam mayalso be scheduled and managed in the mammography management system.Depending on the results of the diagnostic exam (e.g., ACR 4, 5, 6), thepatient may subsequently require a procedural exam 1130, such as abiopsy. The procedural exam 1130 may also be managed in the mammographymanagement system. Managing all such exams in the mammography managementsystem allows the system to link each of the patients and exams togetherand feed back the final outcome data to the relevant individuals asdescribed in more detail below.

With reference to FIG. 12, a procedural flow chart 1200 is shown for theexam creation process for each of the three exam types described above.After a patient physically arrives 1210 at the exam location, afront-desk user of the mammography management system creates the basicexam 1215 information by completing a “create exam” screen of themammography management system, which includes verifying patientdemographic and insurance data and obtaining disclosure sign off fromthe patient. An example of the “create exam screen” 1300 is shown inFIG. 13 and is described in more detail below. After completion of the“create exam screen”, the patient's visit is recognized by themammography system is in the “arrived” state 1220. The “arrived”designation indicates in the mammography management system that thepatient is physically present for the exam to be created, but no studieshave yet been requested. In one embodiment of the present invention, thepatient is in a waiting room when her exam is in the “arrived” state.

Seen in FIG. 13 is an example of the “create exam” screen 1300 displayedby the mammography management system to a front-desk or other user. Thescreen 1300 requests the collection of information including, which isthen entered into the corresponding fields: patient name 1305, date ofbirth 1310, 1315, patient ID 1320, facility where exam is beingperformed 1325, exam type 1330 (screening, diagnostic or procedure),visit/billing ID 1335, scheduled time (time for which the exam isscheduled; may be auto-populated is using the mammography managementsystem scheduler), self referred 1340, referring physician 1345 (may beauto-populated to the patient's primary physician), additionalphysicians 1350, and suppress automatic sending of letters/reports 1355checkboxes. The demographics 1360 and insurance 1365 sections of the“create exam” screen 1300 are pre-populated from the selected patient'srecord. The demographics and insurance data is displayed in order tooffer easy confirmation and modification of patient information asneeded. The disclosure section 1370 of the “create exam” screen 1300allows for the mammography management system to track the sign-off of afacility's legal disclosure document. The system allows for (1) thelegal disclosure document to be presented on paper to the patient andthen gathers the signature on paper, which is indicated by checking the“Signature on File” checkbox 1375, (2) the legal disclosure document ispresented on paper to the patient and then obtains the patient'ssignature electronically from the signature control 1380 on the page,and (3) the legal disclosure is presented electronically to the patientby pressing the “Display Disclosure Signoff Form” button 1385, in whichcase the electronic disclosure is then displayed to the patient in apopup window with a signature control.

After the exam information is collected the front-desk or other user mayeither create the exam and cause the patient's status to change to“Arrived” 1220 by pressing the “Create Exam” button or create the examand then go to the “start exam” page directly by pressing the “Create &Start Exam” button. When either button is pushed the following actionsoccur: an exam record is transmitted to and created in a mammographymanagement system database, the patient's exam status is set to“Arrived” 1220, an exam audit log entry is made to indicate the creationof the exam, the exam is displayed in the facility dashboard arrivedpatients section, the exam is displayed on the arrived patients screenfor the facility. When the “Create & Start Exam” button is pressed, the“start exam” screen will also be displayed. The “Arrived” status 1220 isused to represent the exam state after the completion of the “createexam” screen. Each of the exam workflows in the mammography managementsystem (e.g., screening, diagnostic, and procedure), which are describedin more detail below, initially start in the “Arrived” status.

Again with reference to FIG. 12, at step 1225 a user of the mammographymanagement system next typically completes the next screen, the “startexam” screen. The “start exam” screen is typically populated by a usersuch as a technologist who interviews the patient to determine symptoms,patient medical history and required studies. This type of informationis traditionally not obtained in the waiting room, but rather a privateexam room. Accordingly, the technologist will also have access to acomputer connected to the mammography management system with his or herlogin information. The technologist also requests the initial set ofstudies to be performed. When the technologist completes the start examscreen, the exam will continue the established workflow paths in themammography management system.

FIG. 14 shows a screen shot 1400 of an example “start exam” screen inaccordance with the present invention. In this embodiment, the userinterface includes three general areas of the screen: “start examheader” 1410, “exam type” 1420, and “patient history” 1430. The “startexam header” section 1410 includes fields for patient name—a field thatis dynamically linked to the “view patient” screen—patient date ofbirth, patient MRN, and patient ID number. The “start exam header”section also includes a field labeled “assign to radiologist” 1440. The“assign to radiologist” listbox 1440 includes a selectable list ofradiologist system users who have an association in the system with thefacility where the exam is being created and have Exam Results securitypermission. Selecting a user from the “assign to radiologist” listbox1440 assigns the current exam to the radiologist-user for the entry ofexam results. The “start exam header” section 1410 further includes a“patient symptom diagram” button 1450, the selection of which activatesa popup window 1500 that allows for symptom recordation as seen in FIG.15.

The “exam type” section 1420 of the “start exam” screen 1400 functionssubstantially similarly as for a diagnostic exam and a procedure exam asdescribed below. The “patient history” section 1430 of the “start exam”screen 1400 functions substantially similarly as for the “create exam”process as described below. The fields in the “patient history” section1430 are pre-populated with the most recent exam for the patient.

Once the patient data has been entered, the technologist-user may startthe exam by pressing the “start exam” button 1460 on the “start exam”screen 1400. Upon selection of the “start exam” button 1460, followingactions occur: (1) the entered exam information, including patienthistory, is transmitted to and updated in a mammography managementsystem database, (2) the exam status is set to “pending imaging” 1230(seen in FIG. 12), but if studies have been requested by the user orautomatically by the system, (3) an exam audit log entry is made toindicate the start of the exam, the studies entered by the user arecreated in “requested” status, and the exam is removed from the “arrivedpatients” screen, and the new requested studies are displayed in the“study worklist,” and (4) the user interface returns the system user tothe Arrived Patients screen. If no studies are requested the exam willremain in the Arrived status 1220. If the user presses the Start Exambutton with no studies requested the user receives a confirmation promptindicating that no studies have been requested for the exam. After the“start exam” screen is successfully completed, the exam is set to“pending imaging” status al230 and continues on the procedural workflowpath 1200.

After all relevant patient information is available for the radiologist,but the radiologist has not yet reviewed the information or made arecommendation, the exam status is set to “pending interpretation” 1250.Upon reaching a final conclusion for a study or exam, the radiologistsets the status to “complete.”

With reference to FIG. 16, which shows one embodiment of the “searchexam” screen 1600, and FIG. 17, which shows one embodiment of the“search exam” screen with advance search 1700, the exam search screensallow system users to search for an exam based on entered criteria anddisplays the matching entries in a paginated result list. The userinterface allows system users to search for exams based on the followingfields including patient last name and first name, patient date ofbirth, MRN, patient ID, date of Exam (within a range), radiologist, andfacility where the exam is/was performed. The advance search criteriafurther allow for a system user to search based on the following fields:exam status, exam type, image type, modality device ID, device ID,cancer type, risk factors, referring or additional physician name,priority exams, and exams termed as “false negative.” Results of thesearch are may be sorted based on individual columns of the resultlistings and appropriate pagination will be provided. This functionalityenables additional research capabilities by providing system users toidentify patients and patient exam information based on desiredcriteria. Academic and research facilities may also benefit from thisresearch-supporting functionality.

Worklists

Various worklists are utilized by the mammography management system asdescribed in more detail below. The worklists assist the system users,such as radiologists, and other users involved with the exams, managepatients and exams.

With reference to FIG. 18, an exam worklist screen 1800 in accordancewith one embodiment of the present invention is shown. The exam worklistscreen is used to display all exams assigned to a user, typically aradiologist, or exams that are unassigned but occurring at the user'scurrent facility.

With reference to FIG. 19, a facility dashboard 1900 in accordance withone embodiment of the present invention is shown. The facility dashboard1900 is a display screen that provides a snapshot of a facility'soverall status for the day. Included in the facility dashboard 1900 area pending letters section 1910 (summary of the patient letters waitingto be printed), an unassigned studies section 1920 (summary of thestudies in PACS that could not be automatically associated with anactive patient exam in the mammography management system), an arrivedpatients section 1930 (list of all exams that do not yet have any activeor complete studies), and an active exams section 1940 (list of theexams that are currently in progress, i.e., pending interpretation,pending imaging, or imaging complete). The dashboard screen 1900automatically refreshes at a regular, predefined internal.

With reference to FIG. 20, a study worklist screen 2000 in accordancewith one embodiment of the present invention is shown. The studyworklist screen 2000 presents a count of arrived patients with links topatients' exam screens. In the procedure exam workflow described below,the technologist can signal the assigned radiologist that a patient isready for a procedure to begin by selecting the “ready” link 2010 in thestudy worklist screen 2000 that appears for studies related to procedureexams that are in the “patient prep” status. Responsive to selection ofthe “ready” link 2010, the status of the related exam is changed to“patient ready,” and the study worklist screen refreshes and the “ready”link is no longer be available for the study. The “ready” link 2010 isonly relevant to procedure exams and not to diagnostic or screeningexams.

With reference to FIG. 21, a compare/repeat exam list 2100 in accordancewith one embodiment of the present invention is shown. Thecompare/repeat exam list displays all active exams 2110 that theradiologist has previously classified as either “compare” or “technicalrepeat.”

With reference to FIG. 22, a draft exam list 2200 in accordance with oneembodiment of the present invention is shown. The draft exam list 2200displays the exams saved as draft by the radiologist. The radiologistmay enter the final results by clicking a “results” link 2210.

With reference to FIG. 23, a callback exam list 2300 in accordance withone embodiment of the present invention is shown. The callback exam list2300 displays all active exams that the radiologist previouslyclassified as “callback.” When diagnostic and pathology reports arrivefor these exams the administrator can use the callback exam list toreadily locate the exam and open the final outcome screen by selectingthe corresponding “final outcome” link 2310.

Screening Exams

The mammography management system follows a specific workflow for screenexams. FIG. 24 depicts a procedural flow chart 2400 of the screeningexam workflow through one embodiment of the mammography managementsystem. Table 1 below lists the various exam statuses and thecorresponding condition required for the exam to be placed in theparticular status as used throughout the screening exam workflow.

TABLE 1 Exam Status Description ACR Value Pending Occurs when the examis initially Imaging created by an Administrator and it is not an AnalogImage exam type. Imaging Occurs when the system detects that Completethe study is available in the PACS database. This is also the initialstatus for Analog Image exams. Pending Occurs when the exam is assignedto Interpretation a Radiologist either by the automated scheduler or bya user. Negative Occurs when a Radiologist signs the 1 or 2 negativeresults for an exam. Benign Occurs when a Radiologist signs the 1 or 2benign results for an exam. Callback Occurs when a Radiologist signs 0ACallback results for an exam. Compare Occurs when a Radiologist signs 0BCompare results for an exam. Waiting for Occurs when an Administratorhas 0B Documents printed the letter for a Compare results exam.Documents Occurs when requested comparison 0B Received images arescanned into the system. When a new Exam is created for a patient with aMODALITY = SCANNED, all the Exams for the patient in status Waiting forDocuments are set to Documents Received Send All callback exams whose 0ACertified recommendations were not complied Letter with by the patientswithin 90 days would show up as in the Send Certified Letter status forthe Administrator. The administrator would click on the lost tofollow-up tab and see the list of exams for which certified letters needto be sent. Lost to Occurs when a Radiologist signs-off 0 follow-up on aCallback exam that has been identified as 90 days with no reception ofthe final outcome reports. Completed Occurs after signoff once the1/2/3/4/5/6 letters have been printed to be mailed to the patients. Theexam status becomes complete for ACR values 1 and 2. Draft Occurs whenthe Radiologist save exam results as Draft. Cancelled Occurs when anAdministrator cancels an exam. This is only available prior to theinitial signoff. Technical Occurs when the Radiologist select RepeatTechnical Repeat for the exam results. Waiting Tech Once theAdministrator has printed Repeat the Technical Repeat letters, thestatus is changed to Waiting Tech Repeat and appears in the CompareQueue Tech Repeat Occurs when a new study arrives for Completed apatient that also has an exam in Technical Repeat status. Once a newExam is created for a patient with a EXAMTYPE = TECHNICAL REPEAT, allthe Exams for the patient in status Waiting Tech Repeat are changed toTech Repeat Completed Pending Occurs when the Administrator pressesPathology the Save as Preliminary button on the Final Outcome screen.Documents When a Compare exam waits in Compare Unobtainable status for30 days, the system will detect that is should be change to a Callbackexam. However, the system does not automatically do this, rather thesystem changes the Exam status to Documents Unobtainable and thendisplays the exam to the Radiologist's Pending Exam list

After interpretation by a radiologist, when an exam has negative results(i.e., ACR 1 or 2) (2405 or 2410) a negative exam workflow is followedafter sign-off by the radiologist, including generating and sending anexam results letter 2420 and report 2415 to the patient and referringphysician respectively. The exam is then completed 2425.

When an exam has a compare result (i.e., ACR-0b) 2430, a compare examworkflow is followed an after initial sign-off by the radiologist. Theratings ACR-0a and ACR-0b in the present invention both correspond toACR-0 for the Bi-Rads ratings, which indicates further imaging isneeded. The 0a and 0b ratings are used in the present invention toconvey more information than that conveyed by the ACR-0 Bi-Rads rating;namely ACR-0a and ACR-0b discern between a compare result and callbackresult respectively because the two results yield different workflows.The exam is marked as “compare, possible abnormality” or “compare,essentially normal” by the radiologist on the “exam results” page, and areport is sent 2435 and a letter is generated 2440 for the patientrequesting that the previous films be sent to the facility where theoriginal compare exam was performed. Next, the exam status is set to“compare” and the exam is listed in the “pending patient letters” list.When an administrator prints the letter, the exam status is changed to“waiting for documents,” and the exam is listed in the “compare exams”list of the radiologist who indicated the need for comparison, which istypically the individual who completed the results page. Then, the examis removed from the radiologist's pending exams list.

Upon arrival of the requested images at the facility, an administratorscans the images and enters into the mammography management system thepatient ID via an acquisition station. The scanned images areelectronically transmitted to the PACS database via the mammographymanagement system server as a separate study with a unique DICOM studyID. The mammography management system utilizes the patient ID and tosearch for any existing exams related to the patient with the status of“waiting for documents.” If such an exam is found the mammographymanagement system takes the following steps: (1) create a new historicexam using the information from the DICOM header and relate the exam tothe patient ID, (2) set the status of the existing “waiting fordocuments” exam to “documents received,” (3) display on the “pendingexams list” any exams with either the “pending interpretation” and“documents received” status, (4) remove the exam from the “compareexams” list, (5) receive final results of comparison (e.g., ACR 1 or 2)from radiologist, and (6) generate and mail/fax the exam compare resultsletter 2490 and report 2485. The exam is then completed 2425.

When the radiologist clicks the “results” link related to an exam with a“documents received” status from the “pending exams” list, the “examresults” page is displayed to the radiologist. The exam history is thendisplayed to the radiologist to see the newly created historic exam thatcontains the requested comparison images. If desired, the radiologistmay select “callback, comparison completed” as the result for a compareexam. Upon this selection, the compare exam becomes a callback exam 2445and continues forward with the callback exam workflow described in moredetail below.

When an exam has callback results (i.e., ACR-0a) 2445 a callback examworkflow is followed after sign-off. First, the exam status is changedto “callback,” and a callback letter 2455 and report 2450 are generatedand faxed to the patient and the referring physician respectively. Then,the exam is listed in the callback exam list. The callback resultsletter is printed and mailed, and reminder letters are sent at 30 and 60day intervals if final outcome is not entered. If the patient undergoesthe diagnostic exam, as described in more detail below, the diagnostic2460 and pathology 2465 reports are received and scanned, and theadministrator or lead interpreting physician enters the final outcome,at which point the exam is completed 2425. If the final outcome is notentered into the mammography management system within 90 days, the exammoves to the “lost to follow up” process 2480.

More specifically, when a callback exam is 90 day past due, the “lost tofollow up” exam workflow 2470 ensues, which is initiated when themammography management system detects that an exam in callback status is90 days past creation date. The exam is displayed on the administrator's“lost to follow up” list and is removed from the callback exam list. Thesystem generates the lost to follow up patient letter 2470, and theadministrator prints and mails the lost to follow up letter. The exam ismoved to the pending exams list for the radiologist that provided theoriginal results, and the radiologist may electrically sign the report,thereby resulting in the mammography management system generating 2475the lost to follow up report for all relevant physicians. The examstatus is then changed from callback to lost to follow up 2480.

When an exam is technically inadequate, an exam repeat is required,called a technical repeat. The technical repeat exam workflow beginswhen an exam status is saved as “technical repeat.” The technical repeatletter and report are generated and faxed, and the exam results letteris printed. Next, the status of the exam is changed to “waiting techrepeat,” and the exam now appears in the “compare exam” list. Thepatient then returns for a repeat of the exam, and the new study imagesare transfer to PACS. The PACS trigger creates a new exam as aplaceholder for the images with a status of “complete.” The PACS triggeralso updates the status of the original exam from “waiting tech repeatto “tech repeat completed.” The original exam is moved from theradiologist's “compare/repeat exam” list to the radiologist's “pendingexam” list. Next, the radiologist enters the final results, and the examresults letter and report are generated and faxed. The exam resultsletter is printed, and the exam is completed.

As described, upon viewing and analyzing a screening exam theradiologist enters the results of a mammography screening into an “examresults” screen of the mammography management system. An example of the“exam results” screen 2500 is seen in FIG. 25. When the “exam results”screen 2500 is loaded, the current study images as well as the last twohistorical exam study images for the patient are downloaded from PACS toappropriate viewing software if the images are not already cached.

From the “exam results” screen 2500, the radiologist has access toinformation relating to the patient, relevant patient history, previousexams associated with the patient that are stored in the mammographymanagement system, and other information that may be useful to theradiologist during review of the current exam results. Access in thesystem to additional patient exams allows the radiologist to view theprevious exam results for purposes of comparison with the currentresults.

When the radiologist is prepared to enter screening exam results in tothe mammography management system, he or she may again interact with the“exam results” screen 2500. Under the “breast parenchyma” heading 2510,the radiologist can choose from the following options to reflect theexam results: fatty, average, dense, and dense and nodular. The defaultvalue for this option is average. Under the “benign findings” heading2520, the radiologist may select whether any of the options—calcium,stable mass or implants—are present on the left breast, the rightbreast, or both. If the radiologist selects the implants option, he orshe may further select one or more of the options: sub pectoral, prepectoral, saline and silicone.

Under the “results” heading 2530, the radiologist may select from thefollowing options: “negative, no previous exam,” “negative, no changefrom previous exam,” “compare, possible abnormality,” “compare,essentially normal,” “callback, no previous exam,” “technical repeat,”and “callback, change from previous exam.” Table 2 below lists thevarious screening result options and indicates when they are availablefor selection to the radiologist user.

TABLE 2 Result Description Available Negative, no No previous exams, noneed Initial Result or Tech previous exam to compare (ACR 1 or 2) RepeatComplete Negative, Previous exam (already in Initial Result or Tech nochange from system) reviewed, no previous exam change (ACR 1 or 2)Repeat Complete Negative, After requested documents Comparison Resultcomparison received and Radiologist completed reviewed (ACR 1 or 2)Compare, System does not contain Initial Result or Tech Possibleprevious exam, Radiologist Repeat Complete Abnormality requests (ACR Ob)Compare, System does not contain Initial Result or Tech Essentiallyprevious exam, Radiologist Repeat Complete Normal requests (ACR Ob)Callback, No previous exams, require Initial Result or Tech no previouscallback (ACR 0a) Repeat Complete exam Callback, Previous exam (alreadyin Initial Result or Tech change from system) reviewed, and RepeatComplete previous exam change detected (ACR 0a) Callback, Initially wasa Compare to Comparison Result comparison previous exam, documentscompleted received, more studies needed (ACR 0a) Callback, Could not getprevious Comparison Result previous exams, further studies (only whentimeout unobtainable needed (ACR 0a) waiting for documents) TechnicalExam technically inadequate, Initial Result or Tech Repeat repeat viewsrequired Repeat Complete

If the radiologist selects the result “negative, no previous exam” or“negative, no change from previous exam” under the “results” heading2530 and one of the options under the “breast parenchyma” heading 2510is selected, the ACR rating is automatically set to 1. If theradiologist selects the result “negative, no previous exam” or“negative, no change from previous exam” under the “results” heading2530 and either “calcium” or “stable mass” are selected under the“benign findings” heading 2520, the ACR rating is automatically set to2. If the radiologist selects the result “callback, no previous exam”under the “results” heading 2530, the ACR rating is automatically set to0a. If the radiologist selects the result “compare, possibleabnormality” or “compare, essentially normal” under the “results”heading 2530, the ACR rating is automatically set to 0b.

If the images obtained are blurry, the radiologist selects the result,“technical repeat.” The user can subsequently select one or more of theoptions RMLO, LMLO, RCC, and LCC, to indicate which of the images arenot technically sufficient for reading. Upon signing the report with a“technical repeat” result, the exam status is updated as “technicalrepeat” and a letter is generated and sent to the patient.

The radiologist can also indicate in the mammography management systemwhen the exam is a priority exam by checking the “priority exam” checkbox under the “results” heading 2530. Additionally, even for patientsyounger than 40 years, if the patient has a family history of cancer theradiologist can specify that the patient needs to undergo annualmammograms by checking the check box “negative 1 year follow up due tofamily history” check box under the “results” heading 2530.

If any of the “callback” or “compare” results are selected by theradiologist-user, the radiologist is provided a user interface intowhich to enter and identify an area and type of abnormality. In oneembodiment seen in FIG. 26, an “add lesion” popup window 2600 isautomatically displayed to the radiologist responsive to selection of a“callback” or “compare” result. The popup window can also be displayedmanually responsive to the radiologist pressing the “add” button 2610 onthe “add lesion” popup window 2600. As shown in FIG. 26, the radiologistmay select a plurality of radio buttons specifying the left breast orthe right breast, as well as the area of the breast (e.g., upper-outer,upper-inner, lower-outer, lower-inner, subareolar and axilla) where theabnormality is observed. Radio buttons are provided in each quadrant ofthe breast diagram to mark the type of abnormality (i.e. calcification,mass, asymmetric density, or architectural distortion). The radiologistcan also indicate the size of the abnormality and one or morerecommendations by selecting the appropriate corresponding radio buttonor check box. Pressing the “add” button 2610 saves the entered lesionand clears the “add lesion” popup window for a new lesion entry.Pressing the “finish” button 2620 with no fields populated saves anypreviously entered lesions and closes the popup window 2600.

Lesions that are thereby entered by the radiologist are populated intothe “lesion table” 2550 in the “callback” section 2540 of the “examresults” screen 2500 with a row listing the breast, area, lesion, sizeof abnormality, and recommendations provided by the radiologist. Thelesions are listed on the “lesion table” 2550 in the order they wereentered.

Again with reference to FIG. 25, when the radiologist has completedentering the lesion information, he or she may select the “previewletter” button 2560, thereby causing a pop-up screen containing apreview of the letter that will be sent to the patient. An example ofsuch a letter 2700 is shown in FIG. 27, which includes an electronicsignature box 2710 for the radiologist to sign. When the radiologist hascompleted entering the lesion information, he or she may also select the“preview report” button 2570, thereby causing a pop-up screen containinga preview of the report that will be sent to the referring physician. Anexample of such a report 2800 is shown in FIG. 28, which also includesan electronic signature box 2810 for the radiologist to sign.

As seen in FIG. 27, patient letters may include a recommended time forthe next exam. A set of rules may be used to determine the recommendedtime for the next exam. For example, in one embodiment, the set of rulesis as follows. If “negative 1 year follow up due to family history” ischecked then the letter includes the following recommendation: “Itherefore recommend that you have another mammogram in one year based onyour family history of breast cancer.” Otherwise, if the patient's ageis less than 40, then the letter includes the following recommendation:“I therefore recommend that you have another mammogram at age 40.”Otherwise, if the patient's age is 40 or greater, then the letterincludes the following recommendation: “I therefore recommend that youhave another mammogram in one year.”

Both the letter and report are editable by the radiologist, such thatthe radiologist can make and save changes if desired. Upon completion ofreviewing the report and letter, the radiologist selects the “signreport” button 2580 on the “exam results” screen 2500, which adds theradiologist's signature to the report and letter and moves the workflowto the next step, which typically includes printing of the letter.

Upon completion of the above exam result entry steps, selection of the“view” button 2590 displays to the user the entered details of an exam2900 in read-only format as seen in FIG. 29. All of the information seenin the “view exam” screen 2900 is displayed to the user. Additionally,the letter and report generated by the radiologist are viewable byselecting the corresponding icons 2910 and 2920 respectively.Furthermore, the lead interpreting physician, radiologists, andreferring physicians with appropriate permissions to the mammographymanagement system may select the “download study images” button 2930shown in the upper toolbar, responsive to which the study imagesassociated with the exam are downloaded to the viewing software. The“false negative” checkbox 2940 is available to the lead interpretingphysician and is used to indicate if an exam was falsely screened as anegative.

Diagnostic Exams

When a screening exam uncovers an abnormality, the exam is recorded andstored in the mammography management system as a “callback” result. Thepatient is then requested to obtain a subsequent diagnostic exam. FIG.30 depicts a procedural flow chart 3000 of the diagnostic exam workflowthrough one embodiment of the mammography management system. As resultof a diagnostic exam, an additional procedural exam such as a biopsy maysubsequently be required. Procedural exams are also supported by themammography management system, as described in more detail below. Bymanaging all such exams jointly in the mammography management system,the exams are logically linked together in the system and the finaloutcome data from the exams is stored and maintained in a single logicallocation by the mammography management system. The statuses that can beassigned to a diagnostic exam throughout the diagnostic exam workfloware the same statuses described above with respect to the screening examworkflow.

When the patient arrives at the exam facility 1210, the patienttypically registers at the front desk and fills out the necessarypaperwork, such as insurance forms. Next, the technologist oradministrator interviews patient and creates a diagnostic exam in themammography management system at step 1215. Creating the exam within thesystem requires entry of the reason for the diagnostic exam (e.g., lumpin breast or pain in breast), entry or update of the patient history,and selection of the initial type of imaging study.

If no studies were requested at the time the diagnostic exam wascreated, the exam is assigned a “pending imaging” status 1230 because atleast one study is required prior to review by a radiologist. The examthen is displayed in a special list of exams with no requested/completedstudies that is located on the “technologist dashboard” screen describedbelow. The technologist is thereby informed that the patient is waitingand that the technologist will need to use the “modify exam” screen torequest the initial study.

If studies are requested at the time the diagnostic exam is created, theexam is assigned a “pending imaging” status 1230. Each requested studyis displayed in a “study worklist” for the facility. When alloutstanding requested studies are completed 1240, the exam assigned to aradiologist, is set to “pending interpretation” status 1250, and movedto the assigned radiologist's queue. If no radiologist is assigned, theexam is displayed in the “pending interpretation” queue for anyradiologist that is monitoring the facility. The mammography managementsystem provides the radiologists to ability to assign such exams tothemselves.

When the technologist is preparing to perform the requested study (e.g.,diagnostic mammogram, sonogram, or MRI), the study is pushed frommodality to PACS, wherein the DICOM images are transferred from theacquisition device (e.g., x-ray machine in the case of a mammogram,ultrasound machine in the case of a sonogram, and a magnetic machine inthe case of an MRI) to PACS, and the mammography management systemreceives the notification and creates a study reference to theexam/patient. Upon completion of the study, the technologist enters thestudy completion data, and the exam is then moved to radiologist'sworklist.

Next, the radiologist reviews study and examines patient.Correspondingly, the radiologist opens the “exam results” page in themammography management system to review patient information and theinitial study. Typically, the study is received from the modality on thesoft copy review station (SCW), but in some scenarios the initial studymay be received from the PACS. Prior to final signoff the radiologistcan request an additional study. When this occurs the exam is assignedthe “pending imaging” status. Each requested study is placed in the“study worklist” for the facility and is removed from the radiologist'sworklist while waiting for the imaging to complete.

If additional studies are requested, the technologist reviews “studyworklist” and performs the additional requested study. Accordingly, thestudy is pushed from modality to PACS, and the mammography managementsystem receives the notification and creates a study reference to theexam/patient. Upon completion of the additional study, the technologistenters the study completion data, and the exam is set to “pendinginterpretation” status and moved to the radiologist's worklist.

Next, the radiologist reviews the study images and determines theresults. To review the study images, the radiologist opens the “examresults” screen in the mammography management system and views a listingor all the studies received from PACS. The radiologist views the studyimages and enters the lesions into the mammography management system aspreviously described with respect to the screening exam.

Finally, the radiologist signs off on the exam results as previouslydescribed with respect to the screening exam. To sign off, theradiologist presses the “sign report” button 3110 seen in FIG. 31, inresponse to which the mammography management system generates thepatient letter and physician reports. The letter is generated to reflectthe ACR value assigned based on the radiologist's review of the imagesas described below. If a related screening exam existed for the patientin the mammography management system, the ACR values on the finaloutcome are automatically populated.

When the radiologist signs the results for a diagnostic exam in themammography management system, the system automatically calculates theinitial ACR. If the ACR is 1 or 2 (block 3005) or 3 (block 3010) theexam is considered negative. After the letter is printed the exam is setas completed.

When the radiologist requests previous studies for comparison (ACR 0)(block 3015) the exam is considered a “compare” exam. After the letteris generated for the patient instructing her to provide the previousimages, the exam status is set to “waiting for documents” (block 3020).If the images are obtain within 30 days they are scanned and added tothe exam as a study, and the exam is set to “documents received” status(block 3025) and added back into the radiologist's “pendinginterpretation” worklist for final results. If the images are notreceived within 30 days the exam is set to “images unobtainable” status(block 3030) and still added back in the radiologist's “pendinginterpretation” worklist for final results. When the letters aregenerated in the mammography management system for the final results ofa compare exam, the letter indicates whether the requested images wereor were not received and reviewed.

When the radiologist enters lesions for a diagnostic exam the ACR iscalculated by taking the highest ACR value on all the lesions. If thisvalue is a 4, 5 or 6 (block 3035) a further procedure is required. Theletter sent to the patient informs her of the need to obtain theprocedure. If the patient is in-clinic and the procedure is performedthe same day a letter will still be sent for compliance. The exam isthen set to “pending pathology” status (block 3040). When the pathologyoutcome is entered into the mammography management system, either bysystem update from the related procedure exam or manually, the exam isconsidered complete.

With reference to FIG. 31, the diagnostic exam results screen 3100 isutilized by the radiologist to review patient history and previousexams, to view study images associated with the patient and request newstudies, to record the final outcome ACR for related screening exams,and to enter the study results and impressions for the diagnostic exam.

The “exam information” section 3120 of the diagnostic exam resultsdisplays relevant patient and exam information including details of thediagnostic exam, patient history, and exam history. Clicking the link3130 under “exam type” opens a popup window that display all the reasonfor the diagnostic exam, selections that where made on the “examcreation” screen, and the patient symptom diagram. This display 3200 isshown in FIG. 32.

The “exam studies” section 3140 of the diagnostic exam results screen3100 lists all image studies received from various modalities. Therequested but unfulfilled studies are also displayed in this section.The radiologist may request new studies and cancel studies in requestedstatus in the “exam studies” section 3140. If a study is available inthe mammography management system in digital format it is viewable byselecting the view icon that, when clicked, opens a “view study” screenin a popup window.

If an open callback screening exam (i.e., screening exam in “callback”status) exists for the patient in the mammography management system thenthe “existing callback screening mammogram” section 3150 is displayed,as seen in FIG. 31.

The “link diagnostic results to this screening exam” checkbox 3155causes the screening lesions table to be displayed. Linking thediagnostic results in requires the radiologist to enter the ACR valuefor the screening exam final outcome. The ACR values entered in thissection are stored just as if a user were to add the final outcome forthe screening exam using the existing interfaces in the mammographymanagement system. If the exams are linked when the radiologist pressesthe “sign report” button 3110 on the diagnostic exam results screen3100, the ACR values are populated to the linked screening exam's finaloutcome. If the diagnostic exam's ACR value is 1, 2 of 3, the relatedscreening exam's final outcome is set as complete and no furtherpathology results are required. After the screening exam's final outcomeACR values are updated, the related screening exam status is then set to“complete.”

The “clinical history” section 3160 of the diagnostic exam resultsscreen seen in FIG. 31 includes a text area where the radiologist cantype or dictate freeform text any additional relevant clinical historyinformation.

The “mammographic findings” section 3165 of the diagnostic exam resultsscreen is only displayed if a fulfilled study of type “diagnosticmammogram” is associated with the exam. The “mammographic findings”section 3165 allows the radiologist to enter breast parenchyma, benignfindings, and other results for the diagnostic mammogram study. Thesefindings are previously described with respect to the screening examabove.

The “clinical breast exam” section 3170 of the exam results screenincludes a textbox editable by radiologist to include findings from aphysical examination. The “sonogram findings” section 3175 is onlydisplayed if a fulfilled study of type sonogram is associated with theexam and includes a textbox editable by the radiologist to includefindings from the sonogram study and a “negative” checkbox to indicatenegative results. The “MRI findings” section 3180 is only displayed if afulfilled study of type MRI is associated with the exam and includes atextbox editable by the radiologist to include findings from the MRIstudy and a “negative” checkbox to indicate negative results.

The “impression” section 3185 allows the radiologist to enter theoverall exam results, the diagnostic lesions, and freeform dictation.The radiologist must select one of the following overall results:Negative, ACR 1; Benign, ACR 2; Probably Benign, ACR 3; Lesion Chart.The entries in the “impression” section 3185 are used by the mammographymanagement system to determine the body of the letter and report for thediagnostic exam. Finally, the “diagnostic lesions” section 3190 of theexam results screen includes a table into which the radiologist enterslesions identified during the diagnostic exam.

The “view diagnostic exam” screen is displayed when a user selects toview a diagnostic type exam. FIG. 33 shows a “view diagnostic exam”screen 3300 in accordance with one embodiment of the present invention.Portions of the information displayed on the screen are substantiallysimilar to the “view screening exam” screen. The “exam studies” section3310 includes a “view studies” button 3320, the selection of whichcauses the display of the a selected study. Additionally, the “viewdiagnostic exam” screen 3300 includes further written description of theresults 3330, and the impression 3340 as seen in FIG. 33.

Procedure Exams

A result of a diagnostic exam, an additional procedural exam may berequired. FIG. 34 depicts a procedural flow chart 3400 of the proceduralexam workflow followed at the facility where the exam is performedthrough one embodiment of the mammography management system. Table 3below lists the various exam statuses and the corresponding conditionrequired for the exam to be placed in the particular status as usedthroughout the procedure exam workflow.

TABLE 3 Exam Status Description Arrived Occurs when the patient arrivesat the facility and is checked in by the admissions staff. This is thefirst half of the new two-step exam process. Patient For Procedure examsthe Patient Prep status occurs Prep after the Start Exam screen iscompleted by a Technologist. In order for this to occur at least onstudy must be requested by the Technologist. The Patient Prep statusindicates that the patient is being prepared for the study. The PatientPrep status also occurs when a new study is requested by the Radiologistfrom the Procedure Exam Results screen. Patient For Procedure exams theoptional Patient Ready Ready status occurs when a Technologist indicatesthat the Patient has been prepared for the Radiologist to perform thestudy. However, the study may be started and completed by theTechnologist without indicating that the patient is ready (if theRadiologist is not required to perform the study). Pending After studieshave been completed the status is Interpre- set to PendingInterpretation. tation Pending Occurs when the Radiologist checks thePending Pathology Pathology checkbox on the Procedure Exam Resultsscreen. Pending Occurs when the Radiologist selects the SurgicalSurgical Consultation as a Recommendation on the Procedure PathologyExam Results screen. This indicates that the patient requires surgeryand the exam will be held in the Pending Surgical Pathology until thesurgical pathology results are entered on the Procedure Final Outcomescreen. While in Pending Surgical Pathology status the exam will belisted on the Final Outcome List for the facility. Cancelled Occurs whenan Administrator cancels an exam. This is only available prior to theinitial signoff. Completed Occurs after signoff if a SurgicalConsultation is not recommended. Draft Occurs when the Radiologistpressed the Save As Draft button on the Diagnostic Results screen.

Initially, the patient arrives at the facility (step 1210) and registerswith admissions (step 1215). Demographic and insurance information iscollected from the patient and entered into the “start exam” screen, andthe patient is presented with the disclosure for signature, both aspreviously described. The exam is initially created in the mammographymanagement system with an “arrived” status 1220. The technologistinterviews patient and completes the “start exam” screen (step 1225) inthe mammography management system as previously described by enteringthe reason for procedure exam (e.g., lump in breast, pain in breast,etc), updating patient history as necessary, and selecting the initialtype of study.

Upon completion of the “start exam” screen, the exam status is set to“patient prep” status 3410 and the corresponding study request is addedto the study worklost for the facility. The technologist then preparesthe patient in the room for the requested procedure, and a radiologistis assigned to the exam if one is not already assigned. The technologistthen sets the exam status in the mammography management system to“patient ready” status 3420. The exam is not added to the radiologist'sexam worklist until the status is set to “patient ready.”

The exam is now listed on the assigned radiologist's exam worklist asready for the procedure. The radiologist and technologist then performand complete the requested study/procedure. Upon completion of thestudy/procedure, the study completion data is entered into themammography management system, typically by the technologist. The, thestudy is marked as “completed” 3430 in the mammography managementsystem. The exam is then moved in the system moved to the radiologist'sexam worklist with a status of “pending interpretation” 1250.

The radiologist reviews exams based on the procedure performed byopening the corresponding procedure exam results page in the mammographymanagement system from the exam worklist. If necessary, the radiologistmay request an additional study for more procedures or to take images byadding the request to the study worklist in the mammography managementsystem for the facility. If the radiologist adds an additional request,the study is removed from the radiologist's worklist while waiting forthe imaging to complete, and the exam status is set back to “patientprep” 3410.

The technologist reviews study worklist and performs and completes theadditionally requested study. The study is pushed from modality to PACSin the mammography management system, and the system receives thenotification and creates a study reference to the exam/patient.Technologist then enters the study completion data into the mammographymanagement system. The exam is then moved in the system to theradiologist's worklist with the status of “pending interpretation.”

The radiologist reviews the study images, and enters findings, resultsand recommendations by opening the procedure exam results and viewing alisting or all the studies received by from PACS . The radiologist viewsthe study images with a software viewer, and records the findings andthe lesions results in the mammography management system. When aprocedure is performed, the resultant specimen may need furtherpathology work to be performed to determine the outcome. In such ascenario, the radiologist may still dictate the exam results, but keepthe exam in “pending pathology” status 3440 while waiting for the finalpathology outcome.

The “procedure exam results” screen is utilized by the radiologist toreview patient history including previous exams recorded in themammography management system, to view study images associated with theexam and request new studies, to enter the study findings andimpressions for the exam, and to record lesion procedure results and aexam recommendation. An example of a “procedure exam results” screen3500 in accordance with one embodiment of the present invention is shownin FIG. 35. The interface of the “procedure exam results” screen 3500functions substantially similarly as the “diagnostic exam results”screen described above. One difference is seen in the “exam studies”section 3510, where different types of studies may be requested as seenin FIG. 35. Additionally, all lesions from the linked diagnostic examwith an ACR value of 4, 5, or 6 are automatically populated into the“procedure lesions” table 3520.

Moreover, the procedure exam final outcome screen is used for entry ofthe surgical pathology final outcome of a procedure exam that is in the“pending pathology” status 3440. Each lesion that is indicated as acarcinoma on the “procedure lesions” table 3520 is displayed in thefinal outcome section. A surgical pathology is required to be enteredfor these lesions, and the surgical pathology contains the details ofthe cancer as documented during the actual surgery, versus a biopsy.

Upon completion of the radiologist's review of the study images, theradiologist signs off 3450 on the exam results by selecting the “signreport” button 3530 on the “procedure exam results” screen 3500,responsive to which the mammography management system generates thephysician reports 3460. The exam is then set to the “completed” status3470. Procedure exams do not have an overall ACR value for the outcomein the mammography management system. Rather, they are classified intoone of the following categories: negative, positive, or surgicalconsultation. If the radiologist is still waiting for the pathologywork, he or she may select the “pending pathology” button 3540 on the“procedure exam results” screen 3500, which indicates that the finalpathology has not yet been received.

When the radiologist does enter the final pathology results for aprocedure, the radiologist also enters into the mammography managementsystem an overall recommendation. If the recommendation is for asurgical consultation 3480, a report 3485 is generated for theassociated physicians and the exam is set to “pending surgicalpathology” status 3490. The exam remains in that status until the“procedure final outcome” screen 3500 is completed. Procedure exams inthe “pending surgical pathology” status 3490 are listed on the “examfinal outcome list,” also called the “callback list” for the facility atwhich the exam was created.

As with the other exams, a completed procedure exam can be viewed on the“view procedure exam” screen. An example of the screen 3600 inaccordance with one embodiment of the present invention is seen in FIG.36. The “final outcome” section 3610 of the screen displays the surgicalpathology final outcome for the exam. Only an exam with the “surgicalconsultation” recommendation will have a “surgical pathology” finaloutcome. Accordingly, the “final outcome” section 3610 is only displayedif a final outcome exists for an exam in “completed” status 3470.

Inter-Exam Workflow

Again with reference to FIG. 11, the screening, diagnostic and procedureexams are interrelated. For example and as described above, a screeningexam 1110 that yields an ACR 0 (callback) result requires that thepatient return for a diagnostic exam 1120. A diagnostic exam 1120 thatyields a final ACR of 4, 5, or 6 requires that a patient have aprocedure 1130 performed. If the mammography management system isutilized to support all of these exams, the exams are logically linkedby the system. A linked group of screening, diagnostic, and procedureexams are considered a series, and a lesion number within a linked examseries remains consistent throughout the different exams.

In addition to storing pertinent information of the exams, themammography management system also provides for data exchanges of thelesions, results and final outcome for a logically linked series ofexams, as seen in FIG. 37. For example, a diagnostic exam that is linked(3710) to a screening exam (ACR 0, callback) automatically inherits(3715) through the mammography management system all lesion results fromthe screening exam. The lesion ACR value and diagnostic recommendationfrom the diagnostic exam are also automatically fed back (3720) to thescreening exam final outcome to populate the same.

Similarly, a procedure exam that is linked (3730) to a diagnostic examautomatically inherits (3735) through the mammography management systemany lesion results from the diagnostic exam that have values ACR 4, 5 or6. The needle biopsy pathology from the procedure exam results and thesurgical pathology from the procedure exam final outcome areautomatically fed back (3710) to the diagnostic exam final outcome andto the screening exam final outcome 3750 if the link exists to populatethe same.

Thus, the screening final outcome is automatically populated 3770 basedon results from a subsequent diagnostic exam, and the diagnostic finaloutcome is automatically populated 3760 based on results from aprocedure exam. This linking and automatic data exchange and populationfacilitates information transfer and related efficiencies of themammography management system.

Moreover, when the ACR value and diagnostic recommendations arepopulated from a diagnostic exam result to a screening exam finaloutcome, the “source of diagnostic recommendation” is set to“mammography management system,” and the generated exam report for thediagnostic exam is attached to the diagnostic report field of thescreening exam final outcome. Similarly, when a needle biopsy pathologyis populated into a diagnostic or screening exam final outcome from theprocedure exam result, the “source of needle biopsy pathology” is set to“mammography management system” and the generated exam report for theprocedure exam is attached to the needle biopsy report field of thediagnostic/screening exam final outcome. Likewise, when a surgicalpathology is populated from a procedure exam final outcome to adiagnostic or screening exam final outcome, the “source of surgicalpathology” is set to the same value, and the generated exam report forthe procedure exam is attached to the surgical pathology report field ofthe diagnostic/screening exam final outcome.

Whenever final outcome information is automatically populated to alinked exam, the mammography management system creates an entry in theexam's audit log for the exam that is on the receiving end of the finaloutcome data population.

Studies

When exams have multiple studies, the mammography management systembreaks out the studies into separate tables. This is pertinent to bothdiagnostic exams, which often have multiple related studies, andscreening exams, which only have multiple studies in the case of a“compare” or “tech repeat” result.

When the mammography management system links an incoming study from thePACS system to a diagnostic exam in the mammography management system,the mammography management system matches various fields such as patientname, patient date of birth, and patient MRN. If a match is made and thepatient is associated with an active diagnostic exam created on the sameday as the study was recorded then the study is linked with the patientand diagnostic exam within the mammography management system.

System Administration

The mammography management system provides for a flexible role-basedsecurity model, which complies with HIPAA requirements. The systemprovides for screen access, which protects each specific screen asdesired, functional access, which protects links or other pagefunctions, and data access, which protects stored data.

Every screen in the mammography management system is protected by aspecific permission. Each action that can be performed on a data elementwill also be protected by a specific permission. A user must have therequired permission to gain access to the mammography management systemscreens and certain functions within the screens.

Roles can be created, which include a combination of specificpermissions, and then assigned to the desired users. These roles can bemanaged (created, modified, and deleted) via the mammography managementsystem interface. In order to grant permissions to a user, one or moreroles will be assigned to a single user.

Similarly, the mammography management system includes user managementscreens that allow system users to be added with appropriaterole-association and managed by an administrator. The system alsoincludes “add and modify facility” screens that allow a systemadministrator to add new facilities or modify the details of an existingfacility. The system administrator may also user the mammographymanagement system interface to maintain the details of all remotedevices that are in use at facilities (including home offices), whichconnect to and use the mammography management system service. Further,the system administrator may maintain through the mammography managementsystem interface a list of vendors and models associated with thevendors.

MQSA Audit

The Mammography Quality Standards Act (MQSA) requires that mammographyfacilities meet uniform quality standards, which are intended to lead toearly treatment, a range of treatment options, and increased chances ofsurvival. Under the MQSA, all mammography facilities must be accreditedby an FDA-approved accreditation body and undergo an annual MQSA audit.The mammography management system facilitates such audits as describedherein.

A lead interpreting physician of a facility can generate MQSA auditreports based on various types of filter criteria and comparisons. Withreference to FIG. 38, a MQSA audit screen 3800 is shown in accordancewith one embodiment of the present invention. The lead interpretingphysician or other user may generate reports: by radiologist (compareradiologists to one another), by facility (compare facility to oneanother), overall, by radiologist/overall (compare radiologist tooverall), by radiologist/facility (compare radiologist to facility), byfacility/overall (compare facility to overall). The MQSA audit reportsinclude the following result fields: number of screenings, recall rate(percentage of ACR 0a /total number of screenings), biopsy recommended(number of ACR 0's that ended up as ACR-4 or ACR-5), PPV1 (truepositives; number of ACR 0's that ended up with a final outcome ofcancer, cancers found per 1000 exams read, tumors found (number of stage0 or 1), tumors found (minimal cancer 1, number <=1 cm), node positivity(number that had nodes), false positives(number of ACR 0's that ended upACR-1, ACR-2 or ACR-3), false negatives(number of exams marked asnegative and a cancer was detected in less than 12 months), sensitivitypercentage (PPV1/(PPV1+FNs)* 100), specificity percentage((TNs)/(FPs+TNs)* 100, where number of true negatives is number ofACR-1's and ACR-2's that were not false negatives), number of lost tofollow-up, total number of cancers found during designated period,percentage of cancers that were invasive ductal, percentage of cancersthat were DCIS, percentage of cancers that were lobular, percentage ofcancers that were of the other types, and percentage of 0's that endedup as high risk(LCIS/ADH/High risk).

As the result of an audit, the lead interpreting physician may markexams as false negative in the mammography management system when ascreening mammogram that was originally rated as an ACR BI-RADS 1 or ACRBI-RADS 2, within 12 months is determined to be cancerous. The facilitythat performed the diagnostic procedure will inform the screeningfacility of this occurrence. The lead interpreting physician will beresponsible for searching for the exam and marking it as a falsenegative. Additionally, the mammography management system creates anaudit trail throughout normal usage by tracking, storing, andidentifying users' access of specific records.

Professional Certifications

Professional certifications functionality provided by the mammographymanagement system allow system users such as radiologist andtechnologists to track their professional credentials such as licenses,certifications, and education. The functionality is flexible such that avariety of credential types may be entered and stored in the system andso that the progress of such credentials are tracked and monitored forrelevant continuing education requirements.

Specifically, the professional certifications functionality of thepresent invention provides for receiving from a user the user'sprofessional credential including renewal schedule and requirements,such that the renewal requirements are appropriately defined for thecredential (such as CEUs). The user may then track progress in thesystem against the defined renewal requirement by entering specificinstances of credit. The user may select to receive from the systemreminder emails when his or her credential is due to expire. Further, auser may request from the system a display of all of the user'scredentials. A user may also grant permission to other users to viewupcoming renewals for all users associated with a facility.

Quality Control

The mammography management system of the present invention provides forquality control of devices associated with the system, such asmodalities, monitors used in the radiologists' review station, andprinters. The Quality Control(QC) module of the system defines andexecutes QC tests for medical devices, and includes the ability toconfigure test plans for specific device types, scheduling of QC tests,data entry of QC test information and the ability to generate severaltypes of QC reports.

Specifically, the quality control functionality allows for anadministrator or other user of the system to create a specific QC TestPlan for a Vendor/Model combination, and may include a series of teststo be performed on a designated resource to ensure that the resource isfunctioning correctly. A Vendor/Model combination (type of device) mayhave a single QC Test Plan, which is a collection of QC Tests, each withan occurrence. A QC Test may include a check that the test wasperformed, or it may include a worksheet for data collection. Aworksheet contains one or more fields, which may be simple data entriesor formula calculations. A calculation formula typically includes twooperands and an operator. The operand is either a constant value such as“50” or a reference to the value of another field on the same worksheet.The QC Worksheet screen allows specific data fields to be captured basedon the configuration for the QC test. See FIG. 40. Pressing the savebutton will validate the field and save the data.

The QC Test Dashboard provides a single screen where all due QC Testsfor a facility can be easily viewed and recorded (FIG. 41). The QCDashboard lists all devices that have a QC Test due today or from aprevious day which have not yet been completed. A QC Test that does notrequire a worksheet will allow the user to select a Today checkbox ifthey performed the test today, or optional entry of a different date. AQC Test that requires a Worksheet will provide a link to the Worksheet.Clicking the Worksheet link will open the QC Worksheet screen in apopup.

In order to record QC Test results, the mammography management system isconfigured for each vendor/model that is to be tracked. A vendor/modelhas a specific QC Test Plan in the system that contains one or more QCTests that occur at different intervals. Each test may be a simple asindicating it was completed, or may also include user-defined datafields that to record the various test metrics. The QC test plan setupscreen shown in FIG. 39 allows a series of QC Tests to be defined for aspecified vendor/model. The QC test plan is then applied to all devicesmatching the specified vendor/model connected to the mammographymanagement system.

The QC module further provides the ability to define and generate graphreports that convey the requested fields. To define a report, a selectsa vendor, which causes the vendor's model listbox to populate with thedefined models for the selected vendor. When the user selects a vendor,the system will then populate the worksheet listbox with all of theworksheets that are defined for the vendor/model test plan. The userthen selects the desired worksheet from the worksheet listbox andpresses a load button, which causes a graph report section to bedisplayed which allows the user to select report options and fields tograph.

Although various representative embodiments of this invention have beendescribed above with a certain degree of particularity, those skilled inthe art could make numerous alterations to the disclosed embodimentswithout departing from the spirit or scope of the inventive subjectmatter set forth in the specification and claims.

What is claimed is:
 1. A method implemented by a computer system formonitoring medical imaging quality standards, the method comprising:completing a plurality of worksheet data files, which are selected by auser from a preprogrammed set of worksheet data files templatescorresponding to distinct types of quality control tests, with qualitycontrol data obtained by running a plurality of quality control tests onone or more medical imaging devices, wherein the one or more medicalimaging devices comprises a mammography imaging device, an FFDM imagingdevice, an MRI imaging device, an X-ray imaging device, or an ultrasoundimaging device, wherein a quality control test relates to whether amedical imaging device is functioning correctly and comprises asignal-to-noise quality control test, a contrast-to-noise qualitycontrol test, an artifact evaluation quality control test, a detectorflat-field calibration quality control test, a phantom image qualitycontrol test, a softcopy workstation quality control test or a softcopyworkstation quality level quality control test; and wherein thecompleting of each worksheet data file comprises automaticallygenerating a worksheet data file corresponding to a quality control testrun on a medical imaging device; wherein the worksheet data file isconfigured with preselected data fields defining at least test metricsbased upon the specific medical imaging device type, the date thequality control test was run, an identifier for the medical imagingdevice, and the identity of the quality control test, and automaticallypopulating values in at least some of the preselected data fields andwherein the generating the worksheet comprises displaying on a screen agraphical representation of the worksheet data file corresponding to theselected template and corresponding test as well as an input button thatcan be actuated to confirm completion of the worksheet data file withinthe database and corresponding storage of the completed worksheet and;maintaining a database comprising a plurality of completed worksheetdata files; and generating a report of information collected in at leastsome of the plurality of worksheet data files contained in the database.2. The method of claim 1: wherein a plurality of reports are generated;and wherein the reports are accessible by designated authorized usersthrough a web portal.
 3. The method of claim 1 wherein at least one ofthe preselected data fields comprises a preprogrammed data fieldselected by a user for collecting information.
 4. The method of claim 1wherein the information in the report is defined by a user selectingpreprogrammed criteria.
 5. The method of claim 1 wherein the generatedreport comprises a graph.
 6. The method of claim 1 wherein theinformation in the report comprises results of the quality control testsfor determining whether the medical imaging device is functioningproperly.
 7. The method of claim 1 wherein a quality control test planspecifies a schedule for running the at least some of the qualitycontrol tests on at least one medical imaging device.
 8. The method ofclaim 7 wherein the quality control test plan specifies that the atleast some of the plurality of quality control tests are runperiodically.
 9. The method of claim 8, wherein the occurrencefrequencies comprises daily, weekly, bi-weekly, monthly, quarterly,semi-annually, and annually.
 10. The method of claim 1, wherein some ofthe information entered in the preselected data fields on theperformance of the medical imaging device is received from a testingdevice for measuring the performance of the medical imaging device. 11.The method of claim 1, wherein the quality control test plan directs theperformance of a quality control test on the medical imaging device togenerate data received by a worksheet.
 12. The method of claim 1,wherein the report is based on comparing a test value to a medicalimaging device standard for a pass/fail status, and wherein the testvalue is derived from performing calculations on data received fromperforming a quality control test of the quality control test plan onthe medical imaging device.
 13. A computer system comprising aprocessor, memory and a program that implements the method of claim 1 onthe processor.
 14. The method of claim 1, wherein the report isgenerated for conducting an audit.
 15. The method of claim 1 wherein theentering of values in at least some of the preselected data fieldscomprises the user entering values in at least some of the preselecteddata fields.
 16. The method of claim 1 wherein the test metrics comprisea signal-to-noise and/or contrast-to-noise values.
 17. The method ofclaim 1 wherein the test metrics comprise artifact evaluation data,phantom image data or detector flat-field calibration data.